CTRI/2024/06/068328招募中4 期
A post marketing clinical follow-up study (PMCF) to evaluate safety and tolerability of VELNEZ as a nasal pack after nasal surgery.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subject eligible for use of VELNEZ as a nasal pack post- nasal surgery.
- •2. Male and female in an age group of 18 to 60 years, both included.
- •3. Subjects who can provide written informed consent for participation in the
- •4. Subjects who allow their data to be collected for the study at predefined
- •follow-up periods.
排除标准
- •1.Subject who are unable to be treated with VELNEZ as a nasal packing post-surgery.
- •2. Subject who cannot provide written informed consent for study data
- •collection.
- •3. Subjects unwilling or unable to comply with the postoperative visits necessary
- •for data collection.
- •4. Subject with an active infection at the site of surgery.
- •5. Subject with a history of asthma.
- •6. Subject who are on aspirin/ anti-platelet drugs.
- •7. Hypertensive subjects.
- •8. Subjects who have a history of allergic (Hypersensitive) reactions with any of
- •the ingredients of the device. (i.e Chitosan, Gelatin and Psyllium husk)
- •9. Subject with bleeding disorders.
- •10. Any medical condition that, in the opinion of the investigator, would make the
- •subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease
- •that may interfere with the outcome of the study).
- •11. Subjects with severe inflammation of nasal passages/ sinus cavities.
- •12. Subjects with a history of prospective recurrent rhino sinusitis and subjects
- •with bleeding diathesis.
- •13. Subject found positive for serology.
- •14. Subject on immunosuppressive drugs.
研究者
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